Drawing on experience to achieve IVDR certification

The announcement of the In Vitro Diagnostics Regulation (IVDR) was celebrated as an essential upgrade to in vitro diagnostic (IVD) device regulations in Europe. As the countdown looms to the May 2022 deadline, now is the time for final preparations, and implementing everything that we – the collective industry – have learned.

IVDR will still come into force in May 2022 for new IVDs and Class A non-sterile devices, but it will allow for a more gradual implementation – between 2025 and 2028 – for devices in other classes and in-house assays. Image Credit: Tecan

This article discusses the important changes, challenges and benefits of IVDR, as well as an industry insight into how to work together to ensure IVD devices are, and continue to be, compliant.

The IVDR is the European Union’s regulatory overhaul of pre- and post-market requirements for IVD devices. It came into force in May 2017, with a five-year transition period that was initially proposed to finish on May 26, 2022. This would leave a small window for companies to ensure that their product portfolio was compliant with the new – much stricter – regulations.

However, the COVID-19 pandemic added further strains to already tight timelines, and many companies were forced to switch priorities and divert resources to fight the virus. As a result, the European Commission has recently proposed a more progressive rollout to prevent disruption in the supply of essential healthcare products.

The IVDR will still come into force in May 2022 for new IVDs and Class A non-sterile devices, but it will allow for a more gradual implementation – between 2025 and 2028 – for devices in other classes and in-house assays.

The Commission’s proposal has been accepted by the European Parliament and European Council, and the amended regulation was published and entered into force on January 28, 2022.

What are the main changes under IVDR?

Perhaps the most significant change concerns the classification structure, which organizes IVD devices according to four risk classes, ranging from the lowest (class A) to the highest (class D).

Under the previous regulation, only around 20% of IVD devices needed notified body (NB) approval, with the majority allowed to be self-certified by the manufacturer. In contrast, approximately 80% of devices will need some level of NB oversight under IVDR, not only to bring the product to market but also throughout its entire lifecycle to ensure it remains compliant.

This rigorous post-market surveillance will require manufacturers to update technical information to enable continuous evaluation of new hazards. As technology evolves, it may also be necessary to update risk profiles – for example, to account for changes in antibiotic resistance, new interfering substances or variations in stability profiles – and product performance studies to retain certification.

Importantly, product scope will be expanded to include IVD devices that have come to market quite recently.

The previous directive was launched in 1998, and there have since been several innovations and novel techniques that weren’t covered under that ruling. IVDR is a state-of-the-art regulation with comprehensive coverage of new technologies – such as NGS, POC testing, companion diagnostics, medical software, etc. – that ensures they are clinically relevant and safe for the patient.

There will also be stricter rules on technical documentation and clinical evidence. Currently, manufacturers can use legacy data – original data used when they brought the product to market – but this may no longer be sufficient, and additional studies may be required to prove the continued clinical performance and safety of the IVD device.

Acknowledge the challenges to focus on the benefits

This overhaul will modernize device classification, addressing safety and product concerns that may have slipped through the gaps under the previous directive. But many challenges accompany IVDR, which must also be addressed to make sure they don’t eclipse the benefits.

The extra time and cost involved in gaining IVD device certification will greatly impact manufacturers, especially smaller companies with limited resources.

All manufacturers will be stretched, as there will be increased responsibility to supply technical documentation of a product both pre- and post-market. This may cause some companies to consolidate their portfolios if a product is deemed commercially unviable to continue, potentially restricting the availability of certain IVD devices in the short term.

NBs will also be under unprecedented pressure to certify the mountains of applications coming their way, and so they represent another obvious bottleneck in the timeline.

Furthermore, there will be increased responsibilities across the entire supply chain – including suppliers, manufacturers, R&D teams, sales departments and distributors – where companies will have to establish contracts with all involved parties.

A company will have to know exactly who contributed to the development of the product, helped get it to market and kept it there throughout its entire lifecycle. This will provide greater transparency along the supply chain, but is far more labor-intensive, leading to heightened costs and slower certification if a company is not prepared.

New requirements for sharing information between manufacturers and OEM customers will also come into force. Confidential information and intellectual property aren’t something companies usually want to share but, under IVDR, OEM customers are expected to receive technical documentation on the IVD device.

There are some intricate details of IVDR that still need to be clarified. CE-marked IVD devices, for example, are preferred and, as such, clinical labs will need to evaluate whether there is a commercial alternative for their laboratory developed tests (LDTs), potentially shrinking future innovations in this space. Though how this will affect industry and hospital labs is uncertain.

How has Tecan approached the transition?

Image Credit: Tecan

Tecan has embraced the challenge and prepared from the outset, closely following its recommendation to ‘plan, engage and communicate’.

Planning started directly after the publication of IVDR, including changes to the quality management system, supply chain appraisals for each IVD product and a thorough portfolio review and gap assessment of technical files.

Tecan engaged NBs early, scheduling quality system audits and clarifying product classifications and groupings. It promptly developed a submissions roadmap and, through the entire process, has maintained communication with all internal and external stakeholders to ensure consistency across the board and to manage expectations.

This framework is providing the confidence for timely approval of the IVD device portfolio and, as such, Tecan was one of the first companies to gain IVDR certification for its DHEA Saliva ELISA Diagnostic Assay kit, and the first to undergo an IVDR QMS audit from its NB.

The goal of IVDR is to provide higher quality standards and ensure the delivery of safe, reliable and fully compliant IVD devices from the day they enter the market, for every patient they ever affect.

It has been a steep learning curve for Tecan – and the whole industry – to embark on this arduous task, which is why we must all help each other during the transition. Tecan has provided support and exchanged experiences with its partners to help them mitigate the mistakes the company made early on. This is especially important for smaller companies that may not have the resources to complete the required work for IVDR certification.

These enterprises are crucial in the development of innovative devices, so it is imperative that bigger corporations support them to ensure the IVDR pipeline will continue to be stocked with products that make a difference.

Watch this on-demand webinar – Navigating the transition from IVDD to IVDR – with three leading experts in the field for more information on IVDR. Or visit www.tecan.com/ivdr for a collection of resources to help recertification and ongoing IVDR compliance.

About Tecan

Tecan is a leading global provider of automated laboratory instruments and solutions. Their systems and components help people working in clinical diagnostics, basic and translational research and drug discovery bring their science to life.

In particular, they develop, produce, market and support automated workflow solutions that empower laboratories to achieve more. Their Cavro branded instrument components are chosen by leading instrumentation suppliers across multiple disciplines.

They work side by side with a range of clients, including diagnostic laboratories, pharmaceutical and biotechnology companies and university research centers. Their expertise extends to developing and manufacturing OEM instruments and components, marketed by their partner companies. Whatever the project – large or small, simple or complex – helping their clients to achieve their goals comes first.

They hold a leading position in all the sectors they work in and have changed the way things are done in research and development labs around the world. In diagnostics, for instance, they have raised the bar when it comes to the reproducibility and throughput of testing.

In under four decades Tecan has grown from a Swiss family business to a brand that is well established on the global stage of life sciences. From pioneering days on a farm to the leading role our business assumes today – empowering research, diagnostics and many applied markets around the world.


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